Quality Engineering Tech

Job description

Job responsibilities

• Monitor and compile reports on quality metrics
• Lead and project manage various quality initiatives and processes
• Provide support to product manufacturing processes, including failure analysis and defect containments
• Review shipping and export documents for compliance to regulations
• Perform root cause analysis and propose solutions to challenges encountered
• Continuously implementing items found while interacting with manufacturing and quality processes by identifying areas of opportunity within processes and procedures to improve efficiency, effectiveness, yields,…
• Evaluate product quality by performing material (FQI, IQC, etc.) inspections 4 to 8 hours per week, as needed
• Travel to local tissue harvest sites to address quality events and advise on material requirements up to 8 hours per week, as needed

Job requirements

• Basic understanding of Quality Systems and Regulatory Compliance process including requirements for making process changes
• Technical writing skills including ability to both create and review procedures
• Risk management mindset to drive decisions with a risk-based approach
• Good grasp of basic quality assurance/control processes and tools
• Ability to have positive interactions with employees, vendors, suppliers with varied backgrounds
• Understands data analysis tools and operations (e.g,. Pareto, charts, and trends)
• Bachelor’s degree in engineering (prefer biomedical, mechanical or system), math, physics or other sciences.
• ASQ Certification as Quality Improvement Associate and/or Quality Process Analyst